AI Article Synopsis
- The study aimed to evaluate the safety and effectiveness of combining apatinib and temozolomide in Asian melanoma patients, particularly those with acral and mucosal types who typically respond poorly to traditional therapies.
- A total of 12 patients participated in the trial, with no severe toxicities observed during the dose escalation process; common side effects included mild hypertension and fatigue.
- Results showed that 1 patient had a partial response, 9 had stable disease, and 2 progressed, leading to an objective response rate of 8.3% and a disease control rate of 83%.
Article Abstract
Objective: Asian melanoma patients, predominantly comprised of acral and mucosal subtypes, might not benefit from immunotherapy and targeted therapy as much as Caucasian patients. Novel treatment strategies are demanded after conventional treatment failure. This was a prospective, single-arm, and single-center dose escalation study to investigate the safety and preliminary efficacy of apatinib combined with temozolomide in heavily treated advanced melanoma patients.
Methods: Patients were sequentially admitted to four dose-escalating groups of apatinib and temozolomide (three cases in each group) using a traditional 3 + 3 dose escalation design method.
Results: Twelve patients were enrolled between December 2016 and August 2017. Most patients with an acral or mucosal primary origin progressed after immunotherapy or targeted therapy. Dose escalation had been completed without dose-limiting toxicity. Common adverse events included hypertension, hand-foot syndrome, proteinuria, neutropenia, nausea, and fatigue. All adverse events were grade 1 or 2, while the maximum tolerated dose was not reached. Up to January 2018, 1 patient achieved partial response, 9 experienced stable disease, and 2 exhibited progressive disease. The objective response rate and disease control rate were 8.3% and 83%, respectively.
Conclusions: In conclusion, apatinib combined with temozolomide was well tolerated and has demonstrated efficacy in advanced melanoma patients.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6080644 | PMC |
| http://dx.doi.org/10.1016/j.tranon.2018.07.009 | DOI Listing |
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